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FDA, OSHA Act on Brazilian Blowout

October 8, 2010; updated October 18, 2010, May 24, 2011, and October 21, 2011

FDA has received a number of inquiries from consumers and salon professionals concerning the safety of “Brazilian Blowout” and similar “professional use only” hair smoothing products. The U.S. Occupational Safety and Health Administration (OSHA) issued a Hazard Alert in April 2011 to hair salon owners and workers about potential formaldehyde exposure from working with these products. On August 22, 2011, FDA issued a Warning Letter citing Brazilian Blowout for safety and labeling violations. The following information is intended to answer questions people may have on this subject.

FDA's Role in Regulating These Products

FDA regulates cosmetics, including hair smoothing products, under the authority of the Federal Food, Drug, and Cosmetic Act and, if they are marketed on a retail basis to consumers, under the Fair Packaging and Labeling Act. Under these laws, cosmetics do not have to be approved by FDA before going on the market. However, cosmetics must be safe and properly labeled, and companies and individuals who manufacture or market them have a legal responsibility for the safety and labeling of their products and ingredients. FDA can take action against cosmetics on the market that do not comply with the law. To learn more, see FDA Authority Over Cosmetics.

What This Warning Letter Says About Brazilian Blowout

FDA issues Warning Letters to notify firms or individuals that they have been found in violation of the laws FDA enforces. A Warning Letter also tells what violations need to be corrected in order to comply with the law.

The Brazilian Blowout Warning Letter cites both safety and labeling violations. For example, the letter lists health risks associated with inhaling formaldehyde and reactions that have been reported when people used the product as directed. Among the reported reactions were eye problems, nervous system problems such as headaches and dizziness, respiratory tract problems, nausea, chest pain, vomiting, and rash. The letter also states that the labeling was misleading because it called the product "formaldehyde free," even though people were exposed to formaldehyde when using it as intended. The labeling also failed to reveal possible consequences of using this product under the conditions prescribed in the labels or labeling.

Regulation of Salon Safety

FDA does not have authority over the operation of salons or the practice of cosmetology.

Workplace safety in general, including air quality issues, is regulated by OSHA. Salons are also generally subject to state and local authorities, which may specify safety practices such as assuring proper ventilation.

What OSHA Says About These Products

During investigations, OSHA found formaldehyde in the air when stylists used hair smoothing products, some of which did not have formaldehyde listed on their labels or in Material Safety Data Sheets (MSDS) as required by law. During one investigation, air tests showed formaldehyde at levels greater than OSHA's limits, even though the product tested was labeled as formaldehyde-free. OSHA states that formaldehyde presents a health hazard if workers are exposed. It can irritate the eyes and nose; cause allergic reactions of the skin, eyes, and lungs; and is linked to nose and lung cancer.

For OSHA's complete statement, see Hazard Alert: Hair-Smoothing Products That Could Release Formaldehyde.

Similar Products That Use Formaldehyde-related Ingredients

The Brazilian Blowout Warning Letter should not be interpreted as a broad evaluation of the safety of hair-smoothing products or such ingredients as formaldehyde, methylene glycol, or other formaldehyde-related ingredients. Other hair-smoothing products may vary with respect to composition, intended conditions of use, and other factors. FDA continues to evaluate these products for safety and labeling on a case-by-case basis.

FDA's Advice to Consumers

Skin sensitivity can develop after repeated contact with formaldehyde-related ingredients. When formaldehyde is released into the air it can cause serious irritation of your eyes, nose and lungs. It is recommended that you limit your exposure to products that contain formaldehyde-related ingredients to reduce these health risks.

Read the label. If you're purchasing a product on a retail basis, whether at a store or by mail order, including on the Internet, the product is required to have a list of the ingredients. If it doesn't, please let FDA know. The list of ingredients is required under the Fair Packaging and Labeling Act. Here are some ingredients to look for:

Formaldehyde
Formalin
Methylene glycol

Ask your salon professional. Products that are marketed only to salon professionals may not have a list of ingredients, because the Fair Packaging and Labeling Act doesn't apply to them. They are required, however, to have directions for safe use, and OSHA requires them to have an MSDS. You can ask salon professionals if they know whether a product contains formaldehyde-related ingredients or other ingredients you may wish to avoid. In its Hazard Alert on formaldehyde dangers to hair salon owners and workers, OSHA addressed the information companies should provide to salon workers in an MSDS. However, as OSHA also pointed out, the MSDS for Brazilian Blowout did not contain all the required information.

Report bad reactions. Consumers are one of FDA's most important sources of information, especially because the law doesn't require cosmetics to be approved by FDA before they go on the market. To report a reaction to a cosmetic product, use one of these contacts:

1) Reporting by phone to the Consumer Complaint Coordinator at your nearest FDA district office. Phone numbers are posted on FDA's Web page, Consumer Complaint Coordinators, and in the Blue Pages of the phone book, generally under United States Government/Health and Human Services.

2) Reporting online to FDA's MedWatch adverse event reporting system. You also may call Medwatch at 1-800-332-1088 to request a reporting form by mail.

Salon workers also can file complaints about unsafe workplaces with OSHA, as stated in OSHA’s Hazard Alert.

Where to Learn More

For information on workplace exposure to formaldehyde, see Formaldehyde on OSHA’s website. The National Institute for Occupational Safety and Health (NIOSH) at the Centers for Disease Control and Prevention also has published resources on formaldehyde on its website under Formaldehyde: NIOSH Resources.

FDA will continue to monitor safety issues regarding hair-smoothing products and will report on any new developments.